CVD drug regulatory watch
Newly minted FDA commissioner gets an earful of prasugrel
The new US FDA commissioner Dr. Margaret Hamburg is under attack on the issue of prasugel. The regulatory body’s Cardiovascular and Renal Drugs Advisory Committee unanimously recommended the approval of the drug in February of this year based on the results of the TRITON-TIMI 38. However, many health experts are not convinced of the trial results, which they claim are “flawed” and requests the FDA to “stop considering prasugrel for approval until the completion of additional studies that aren’t flawed.” Prasugel is anti-platelet agent indicated for the treatment of acute coronary syndromes and is a product of Lilly/Daiichi Sankyo.
CVD medical advisory watch
AHA/ASA science advisory recommends use of tPA between three and 4.5 hours after stroke
The American Heart Association and the American Stroke Association jointly issued a new science advisory this month that supports the use of the clot-buster drug tissue plasminogen activator (tPA) to treat acute ischemic stroke even three to 4.5 hours after onset of symptoms. Previously, tPA treatment was only recommended within 3 hours of symptom onset. The new recommendation is based on the results of European Cooperative Acute Stroke Study 3 (ECASS 3). However, despite this “longer time window for treatment“, the advisory strong emphasizes to avoid delays in diagnosis and treatment.
CVD research study watch
A new report by the Department of Health & Human Services’ (HHS) Agency for Healthcare Research and Quality (AHRQ) states that there is insufficient evidence to support the benefit of genetic testing for two gene mutations Factor V Leiden (FVL) and prothrombin G20210A in people with a history of blood clots. Some researchers believe that testing for the mutation can help prevent deep-vein thrombosis by prescribing blood-thinning drugs as prophylaxis. However, the AHRQ study found current research evidence insufficient and calls for addition large, randomized clinical trials.
CVD food issue watch
“Caution: this place is bad for your health.” Says the sign outside the door. Yet, the Heart Attack Grill in Arizona is cashing in on food that can kill and yet people keep coming. The menu says it all: bypass burgers, flatliner fries, and jolt cola. And the waitresses are dressed like nurses. Next week, I’ll be writing an in depth post on why this overtly unhealthy restaurant is attracting lots of followers.
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